Regulatory Compliance Specialist (m/f/d)

Seniority Level Employee Job Category Pharma & Chemistry & Life Science Percentage 100 % Job Type Temporary Reference No. KWI-PC-T-55169 Description ### As a first-tier supplier of our renowned business partner, Roche Diagnostics in Rotkreuz, we are looking for a motivated and committed Regulatory Compliance Specialist for a temporary assignment of 6 months, starting immediately. In this role, you will take on the independent regulatory verification and assessment of third-party products (3rd Party Products) with regard to the applicable European (EU-MDR / EU-IVDR) and Swiss regulations (MepV / IvDV). Tasks & Responsibilities ### • Regulatory Verification: Independent examination and assessment of technical documentation, Declarations of Conformity (DoC), CE certificates, and labeling of 3rd-party medical devices and in-vitro diagnostics, as well as checking the correct labeling regarding CH-REP (Swiss Authorized Representative) and importer obligations according to MepV/IvDV. • Vendor & Partner Management: Communication with suppliers and partners to request, review, and clarify missing regulatory evidence and quality agreements. • PRRC Support: Creation of recommendations for the release or blocking of third-party products for the Swiss market. • Operational Support in the Regulatory area as needed: Including supplier inquiries and document review. Must-Haves ### • Successfully completed studies in the field of medical technology, natural sciences, industrial engineering, or a comparable qualification • Demonstrable, multi-year (3+ years) professional experience in Regulatory Affairs / Quality Management in the Medtech or IVD sector • Profound knowledge of the EU-MDR (2017/745) and EU-IVDR (2017/746) • Profound knowledge of the Swiss Medical Devices Ordinance (MepV) and In-vitro Diagnostics Ordinance (IvDV) • Practical experience in auditing, releasing, or verifying supplier and third-party documentation (3rd-party processes) • Business fluent German and English in spoken and written form Benefits ### • Become part of one of the most renowned pharmaceutical companies and actively help shape the future of healthcare • Experience a corporate culture that promotes diversity and inclusion and in which all employees feel valued • Work on a state-of-the-art campus with green spaces, meeting zones, and an inspiring atmosphere • Work with modern and up-to-date tools in an innovative working environment • Start with professional onboarding and a thorough introduction to your new role during the Welcome Days • Benefit from financial support for your professional continuing education plans • Enjoy a selection of high-quality food in modern company restaurants • As part of a sustainable mobility concept, on-site parking is available to you (according to internal guidelines) • Take advantage of unbeatable, year-round discounts at well-known retailers and over 200 top brands • Benefit from fleet discounts when purchasing new cars or receive ongoing discounts on fuel with our fuel card Are you interested? Do not hesitate and submit your complete application documents to us online today. We look forward to meeting you!